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Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury

A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03874247
Enrollment
94
Registered
2019-03-14
Start date
2019-02-25
Completion date
2019-12-31
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Traumatic Injury

Brief summary

A randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial

Interventions

DRUGpelubiprofen 45mg

bid for 3 days after meal

DRUGpelubiprofen placebo

bid for 3 days after meal

Sponsors

Daewon Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Double-blind

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patient, ages over 19 years * Patients with post traumatic acute pain within 48 hr(sprain/strain) * Patient whose pain scale is over 50 mm(VAS score)

Exclusion criteria

* Patients with chronic pain * Presence of a fracture or more than one injury * Previous adverse reaction or known allergy to NSAIDs

Design outcomes

Primary

MeasureTime frameDescription
SPID-D3Day 3Sum of Pain Intensity Differences(100 mm pain VAS)

Countries

South Korea

Contacts

Primary ContactMOON
moonyw@daewonpharm.com+82-2-2204-7094

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026